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Phase 3 Randomized, Double‑Blind Study of Telitacicept versus Placebo for Efficacy and Safety in Adults with Active Primary Sjögren’s Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Primary Sjögren’s Disease, an autoimmune condition in which the body’s immune system attacks moisture‑producing glands, leading to dry eyes, dry mouth, and sometimes joint pain or fatigue. The investigational treatment is a subcutaneous injection (given under the skin) of Telitacicept, a drug designed to modify the immune response. Participants will receive either the active drug or a placebo, which looks the same but does not contain the active ingredient.

The purpose of the trial is to determine whether Telitacicept can safely improve disease activity compared with placebo over a period of about one year. Participants will attend regular clinic visits where they will receive their assigned injection, have blood tests, and undergo simple assessments such as measuring saliva production (how much saliva is made when the mouth is at rest and when stimulated) and an eye test called Schirmer’s test (which measures tear production). Throughout the study, doctors will track changes in symptoms and overall health to evaluate the drug’s effect.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessments

    After joining the study, you will complete the required consent form and then undergo a series of baseline measurements. these include the essdai score (a questionnaire that rates disease activity), the clinessdai score, the physician’s global assessment of disease activity, stimulated and unstimulated whole salivary flow tests, the schirmer’s test (which measures eye moisture), and quality‑of‑life questionnaires such as the sf‑36 and facit‑f. these measurements establish your starting point for later comparisons.

  2. Step 2

    Randomization and first injection

    Based on a computer‑generated random assignment, you will receive either the active medication telitacicept or a matching placebo. the assigned product is given as a subcutaneous injection of 160 mg. this first injection is administered at the clinic under medical supervision.

  3. Step 3

    Ongoing treatment and regular study visits

    You will continue to receive the assigned injection according to the study schedule for a total duration of 48 weeks. at each scheduled visit you will:

    • receive the next subcutaneous injection of 160 mg (or matching placebo)

    • undergo safety checks, including blood tests and physical examinations

    • have the essdai and other disease‑activity scores repeated

    • repeat salivary flow measurements and the schirmer’s test as required

    • complete the same quality‑of‑life questionnaires used at baseline.

  4. Step 4

    Mid‑study assessments

    Around the middle of the treatment period (approximately week 24), additional assessments are performed to evaluate progress. these include the same set of disease‑activity scores, salivary flow tests, eye moisture test, and questionnaires. the results are compared with the baseline values to see any changes.

  5. Step 5

    Week 48 final evaluation

    At the end of the 48‑week treatment period, a comprehensive final visit is conducted. you will receive the last injection, and the full set of assessments described earlier is repeated. the primary goal is to determine the change in the essdai score from baseline. secondary goals include changes in other scores, salivary flow, eye moisture, and quality‑of‑life measures.

  6. Step 6

    Study completion

    After the final evaluation, the study treatment phase ends. you will be informed about the overall study results in a general manner, and any further care will be arranged by your regular health provider.

Who can join the trial?

4 criteria

  • You must be a man or woman who is between 18 and 75 years old at the time of screening.
  • You must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjögren’s syndrome, which are a set of medical guidelines used to confirm this condition.
  • Your disease activity score called ESSDAI must be **5 or higher** at screening. The ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) measures how active the disease is, but the score is calculated without looking at kidney, lung, or nerve involvement.
  • You must test positive for antibodies to Sjogren’s Syndrome A (SSA) or Anti‑SSA (Ro) at the screening visit. Being seropositive means these specific immune proteins are found in your blood.

Who cannot join the trial?

5 criteria

  • Having another major immune‑system disease (for example, rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis) that could explain most of your symptoms instead of Primary Sjögren’s Disease.
  • Having a different autoimmune or inflammatory condition (such as systemic sclerosis, inflammatory bowel disease – long‑term inflammation of the digestive tract, or gout – painful joint attacks) that might make it hard to see how Primary Sjögren’s Disease responds to treatment.
  • Having severe fibromyalgia – a condition that causes widespread muscle pain and fatigue – which could interfere with measuring improvement in Primary Sjögren’s Disease.
  • Having active life‑threatening (could cause death) or organ‑threatening (could damage major organs) complications of Primary Sjögren’s Disease at the time of screening.
  • Having a serious, uncontrolled medical problem in any body system that is not related to Primary Sjögren’s Disease (for example, poorly controlled asthma, cardiovascular disease – heart or blood‑vessel problems, very high blood pressure (hypertension), or major depression) that the doctor believes would prevent safe participation.
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Investigated drugs

Telitacicept injection is a medication that is given as a subcutaneous (under‑the‑skin) injection using a pre‑filled syringe. It contains a protein designed to calm down specific parts of the immune system that are over‑active in primary Sjögren’s disease. In this trial the drug is being tested to see if it can reduce the disease’s symptoms and improve patients’ overall health and quality of life over a period of 48 weeks.

What is already known about the treatment

Telitacicept injection - Telitacicept injection is given as a subcutaneous injection using a pre‑filled syringe that contains a clear solution. The drug is an investigational biologic currently in Phase 3 trials and has not yet received full market approval. It is being studied for the treatment of active primary Sjögren’s disease, an autoimmune disorder that reduces moisture production. Telitacicept is a fusion‑protein inhibitor that binds to the BAFF and APRIL proteins, blocking signals that keep B‑cells alive, which reduces immune activity and inflammation.

Investigated diseases

Primary Sjögren’s syndrome - Primary Sjögren’s syndrome is an autoimmune disorder that mainly damages the glands that produce tears and saliva. It causes persistent dryness of the eyes and mouth, which can lead to irritation and difficulty swallowing. Over time, the dryness may spread to other mucous membranes and the skin. Some patients develop swelling of the salivary glands or joint discomfort. The disease can also involve the kidneys, lungs, or nervous system in a gradual manner.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525556-28-00Protocol codeRC18G007Estimated enrolment189 patientsSponsorVor Biopharma Inc.

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